26/02/2017 Understanding the Cleaning Validation Processes

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UnderstandingtheCleaningValidationProcesses
KnowandunderstandthecleaningprocessesyoumustvalidateDawnTavalskyoratedinthefinaleofher
workshopat17thAnnualValidationWeek.AccordingtoTavalsky,theFDAprocessvalidationstagescanapplyto
cleaningvalidation.Stage1arethephasesthatprecedethepurificationstepsStage2involvesthestepsregarding
productpurificationandconjugationStage3isthefinalformulationandfilling.

Tavalskycontinuedtoemphasizetheimportanceofunderstandingcleaningequipmentandequipmentflow.
Explaininganexampleofequipmentflow,TavalskysaidEquipmentcancomeintothecentralcleaningservices
areaandanyofthatequipmentcangobackouttoanyoneofthosebuildingsagaineverythingisshared,
nothingisdedicatedfromavalidationperspective,thatshugelydifficult.

Tavalskyalsodiscussesdifferentcleaningsystemsnamelycleaninplace(CIP),cleanoutofplace(COP),cabinet
washer,andmanualcleaning.FocusingonfirstCIP,TavalskyexplainedtheintricaciesofCIPflow.

Movingnexttomanualcleaning,sheaskscanyouvalidatemanualcleaning?Tavalskyarguesthatyoucan
proceduresjustneedtobespecific.Thereisadifferencebetweena200pound,sixfoottwomananda140pound
woman.Theyregoingtoscrubdifferentlytheyaregoingtohavedifferentpressurestheyapply.Youhaveto
makethecleaningprescriptiveenoughthatitworksfortheworstcasesituation,Tavalskysayswithasmile,Idont
wanttocallawomantheworstcasesituation,butwhenitcomestoforce,shemightbe!Theotherproblemwe
havewithmanualcleaning,Tavalskycontinues,isthattheequipmentcancomeatyouindifferentsoillevels.For
example,whenmanuallycleaningatank,atankcanbeaquarterfullofmaterialoralmostnoneatall.Wegotto
dowhatwecallgrossdebrisremoval.Thisisaprocessthatprecedescleaningvalidationwhereintheequipment
iscleanedtoavisuallycleanbaseline.

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